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Safety Trial of F-60 Among Children Hospitalized With SAM

NCT07752628 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2026-08-07

No results posted yet for this study

Summary

The current WHO-recommended F-75 diet for stabilization of SAM has remained largely unchanged since its development in the 1990s. No clinical trial has studied enhanced therapeutic formulas during the stabilization phase, particularly in high-burden, low-resource settings. Additionally, the current F75 nutritional formula was based only on expert opinion, not scientific evidence.

Evidence suggests that modifying the nutrient profile of stabilization formulas may improve survival, reduce complications such as refeeding syndrome, and enhance early recovery. A better stabilization formula for these medically fragile children has the potential to reduce mortality. The purpose of this randomized controlled clinical trial (RCT) is to test the hypothesis that an enhanced nutrient fortified therapeutic stabilization formula (F-60) will improve outcomes for children hospitalized with SAM, relative to the current standard of care (F-75).

Hypothesis: The main hypothesis of this safety study is that F-60 is not inferior to F-75.

Objectives:

To test this hypothesis, Investigators will pursue two specific aims. Aim 1: to assess laboratory outcomes in children stabilized with F-60. Aim 2: to assess clinical outcomes in children who receive F-60.

Conditions

  • Dietary Supplementation
  • Severe Acute Malnutrition
  • Children

Interventions

DIETARY_SUPPLEMENT

F75 milk feeds

Standard 'F75' (77 kcal/100 ml) provides 95 kcal/kg/day

DIETARY_SUPPLEMENT

F60 milk feeds

F-60 contains 60 kcal/100ml, and provides 78 kcal/kg/day

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07752628 on ClinicalTrials.gov